Drug News
Pfizer receives FDA approval for Eraxis to treat candidemia
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Pfizer said today that Eraxis (anidulafungin) has been approved by the U.S. Food and Drug Administration to treat candidemia, a potentially life-threatening bloodstream infection. Candidemia is the most deadly of the common hospital-acquired bloodstream infections, with a mortality rate of approximately 40 percent.
In the United States, candidemia affects approximately one in 5,000 people, resulting in an estimated 60,000 cases each year. “Bloodstream infections such as candidemia can spread quickly and are very dangerous, especially for patients with weakened immune systems,” said Dr. Joseph Feczko, Pfizer’s chief medical officer. “Physicians treating these seriously ill patients now have an important new treatment in Eraxis.”
Ebola DNA vaccine shows promise
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Vical Incorporated has announced that an Ebola vaccine candidate administered using Vical’s proprietary DNA delivery technology was safe and well tolerated, and produced both antibody and T-cell Ebola-specific responses in all healthy volunteers who received the full 3 doses of vaccine.
The Phase 1, randomized, placebo-controlled, dose-escalation study, the first human trial for any Ebola vaccine, was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and conducted at the NIH Clinical Center. The data were presented at the American Society for Microbiology (ASM) 2006 Biodefense Research Meeting in Washington, D.C., by Julie E. Martin, D.O., a trial investigator and research scientist at NIAID’s Dale and Betty Bumpers Vaccine Research Center (VRC), which developed the vaccine. The DNA vaccine used in the Phase 1 trial incorporates genetic material encoding core and surface proteins from two strains of Ebola. Vical has secured a nonexclusive license from the NIH to proprietary gene sequences used in the vaccine.
New drugs, deals seen boosting biotech in 2006
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The biotechnology sector looks set to grow again in 2006, helped by new drug approvals, a relative lack of generic competition and the eagerness of big drug companies to partner with—or acquire—those with products at early stages of development, analysts said.
“It’s been about three years since biotech bottomed out, and this bull period feels much more controlled and sustainable than others,” said Eric Schmidt, an analyst at SG Cowen & Co.
Over the next three days executives from more than 30 biotechnology companies will discuss the future of their new products, the potential for collaborations, and the regulatory environment at the Reuters Biotechnology Summit to be held in London, Boston and Los Angeles.
FDA proposes definition for whole grains
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The U.S. Food and Drug Administration said on Wednesday it has formulated a new definition of whole grain that will make it easier for consumers to follow a healthy diet.
It is the first time the FDA has issued a specific definition for consumers and the food industry of what it considers to be whole grain.
WHO urges international action against fake drugs
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The World Health Organization (WHO) appealed on Tuesday for international action against fake and mislabelled medicines, estimated to account for 10 percent of drugs sold worldwide.
In a statement issued ahead of a high-level meeting of regulatory, pharmaceutical industry and consumer representatives in Rome, the United Nations health agency said that a global task force ought to be set up to fight drug counterfeits.
US advisers criticize FDA drug safety board
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Some outside advisers on Friday criticized a major part of the government’s efforts to improve drug safety, saying a new oversight board needs independent voices and should consider meeting in public.
The Drug Safety Oversight Board was announced a year ago as a step to help regulators quickly respond to signs of unexpected side effects after a drug reaches the market.
FDA affirms safety of Aspartame
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The Calorie Control Council has stated that a rat study conducted by Italy’s Ramazzini Institute is totally contradictory to the extensive scientific research and regulatory reviews conducted on aspartame. The U.S. Food & Drug Administration (FDA) has said they are not recommending any changes in the use of aspartame.
According to Dr. George Pauli of the FDA, “FDA requested the data from the Ramazzini study in July 2005 but we have as not yet received the data. The agency cannot, therefore, comment on the study until it has the opportunity to review the study data, in depth. Based on the large body of evidence we have reviewed, including several studies on carcinogenicity, which showed no adverse effects and data on how aspartame is metabolized by humans, we have no reason to believe that aspartame would cause cancer. Thus, it remains FDA’s position that use [of aspartame] is safe.”
Misuse led to drug-resistant flu strains -experts
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Misuse of two anti-viral drugs in China, Russia and other countries likely led to the development of resistant influenza strains against which the drugs are now nearly useless, health experts said on Thursday.
The medicines involved are amantadine and rimantadine, used to treat common seasonal influenza but not intended to combat the avian flu strain that has killed at least 85 people since 2003 and which experts fear could mutate and cause a global pandemic.
Pharmacists sue Walgreen over contraceptives
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Four Illinois pharmacists have sued U.S. drugstore chain Walgreen Co., saying they were wrongly fired for refusing to dispense the “morning-after” emergency contraceptive pill.
The four are represented by the American Center for Law and Justice, a conservative legal group founded by Christian evangelist Pat Robertson.
Anti-cholesterol drugs can cut sepsis risk: study
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Cholesterol-lowering drugs called statins can reduce the risk of severe infection in patients suffering from heart disease or stroke, scientists said on Wednesday.
Statins lower cholesterol by inhibiting an enzyme that controls how much of this fat is produced in the body.
US FDA warns Bayer on hemophilia therapy promotion
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A number of Bayer AG promotions for its hemophilia treatment Kogenate FS ae misleading because they fail to include ample information about risks and directions for use, U.S. regulators said in a letter released on Tuesday.
The Food and Drug Administration objected to letters to patients and doctors about a free trial program for Kogenate FS.
OTC weight loss drug offers benefits
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The first diet drug aimed at helping the growing number of fat Americans lose weight moved one step closer to U.S. approval of over-the-counter availability on Monday after a U.S. Food and Drug advisory panel endorsed the idea.
Called Alli, GlaxoSmithKline Plc’s low-dose version of the prescription drug Xenical (orlistat) is generally safe and effective for adults when used for six months, the U.S. Food and Drug Administration’s advisers said.
FDA to propose guidelines on med device reports—NYT
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The Food and Drug Administration will soon propose guidelines meant to make the annual safety reports filed by manufacturers of medical devices more complete and more accessible to the public, The New York Times reported on Saturday.
Dr. Daniel Schultz, the director of the FDA’S Center for Devices and Radiological Health, told the newspaper that the changes were part of a wider effort to improve the agency’s monitoring of medical devices after they are approved for sale.
FDA unpopular over label liability revamp
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The Food and Drug Administration in the U.S. has said that federally approved drug labels pre-empt state liability laws and are part of a revamp of the lengthy, hard-to-read instructions that come with medicines.
It also says that the pre-emption of state laws address drug makers’ concerns that the streamlined summary of risks could increase their liability if patients alleged the warnings were inadequate.
Impotence drugs linked to eye damage risk - study
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Impotence drugs such as Viagra and Cialis can increase the risk of eye damage in men who have a history of heart disease or high blood pressure, researchers said on Tuesday.
In a small study, scientists at the University of Alabama in Birmingham found that men who had suffered a heart attack were 10 times more likely to have optic nerve damage if they had been taking leading anti-impotence pills.
